A Randomized Phase II Study to Evaluate the Effect of Two Different Doses of Enoxaparin Sodium in Combination With Standard Chemotherapy (Cisplatin Plus Etoposide) With Respect to Time to Tumor Progression (TTP) in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer (SCLC) Without Underlying Venous Thromboembolism

Inclusion Criteria:

- 18 years of age or older

- Histologically or cytologically documented extensive disease small cell lung cancer.
Only small cell histology is eligible. Mixed histology is not eligible. Patients
who are considered to have operable disease are not eligible

- Radiographic measurable disease by RECIST criteria

- Life expectancy of greater than 4 months and ECOG Performance Status of less than or
equal to 2

- Patients must be an appropriate candidate for the standard combination of cisplatin
and etoposide for SCLC. There are no restrictions on radiotherapy

- No prior chemotherapy for SCLC cancer

- Participants must meet the hematological, renal and hepatic function requirements
outlined in the protocol

- If brain or bone metastases are present at the time of initial diagnosis, patients
must have completed radiation treatment at least 2 weeks before starting the study

- No active uncontrolled infection

- No other serious illness or medical condition that in the opinion of the investigator
would be expected to interfere with the subject's ability to receive study treatment
or comply with study procedures

Exclusion Criteria:

- New (defined as 6 months or less) or symptomatic thrombosis at the time of enrollment

- Indication for anticoagulant treatment such as mechanical heart valves, atrial
fibrillation, or previous VTE

- Contraindication or known hypersensitivity to LMWH or unfractionated heparin (UFH)

- Active bleeding disorder

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant or breast feeding women

- Individuals with a history of a different malignancy are ineligible except for the
following circumstances. Individuals with a history of other malignancies are
eligible if they have been disease-free for at least 5 years and are deemed by the
investigator to be at low risk for recurrence of that malignancy. Individuals with
the following cancers will are eligible if diagnosed and treated within the past 5
years; cervical in situ, and basal cell or squamous cell carcinoma of the skin

- HIV-positive individuals on combination antiretroviral therapy are ineligible